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Clinical Trial
. 2021 Jul;29(7):3783-3792.
doi: 10.1007/s00520-020-05902-2. Epub 2020 Nov 24.

Smartphone measurements of physical activity and fitness are associated with early trial discontinuation of patients in (hemato)oncology phase I/II clinical trials

Affiliations
Clinical Trial

Smartphone measurements of physical activity and fitness are associated with early trial discontinuation of patients in (hemato)oncology phase I/II clinical trials

Joeri A J Douma et al. Support Care Cancer. 2021 Jul.

Abstract

Background: Patients, who discontinue early, do not benefit from phase I/II clinical trials (early-phase clinical trials (EPCT)). In this study, associations between objective smartphone measurements of physical activity and fitness and early trial discontinuation in patients with cancer participating in EPCT were investigated.

Methods: Before start of treatment, physical activity (steps/day) and physical fitness (meters walked in 6 min) were measured with a smartphone, and patient-reported physical function (PRO-PF) was assessed (EORTC QLQ-C30-PF). Early trial discontinuation was defined as discontinuation ≤ 28 days. Univariable logistic regression analyses were performed to study associations of physical activity, fitness, and function with early trial discontinuation. Optimal cutoff values of physical activity and fitness were assessed with ROCs, based on positive predictive values (PPV).

Results: Median (interquartile range (IQR)) step count was 4263 (2548-6897) steps/day, mean ± standard deviation 6-min walking distance was 477 ± 120 m and median (IQR) PRO-PF score was 83 (67-95) points. Fourteen patients (12%) discontinued the trial early. Smartphone measurements of physical activity in units of 100 steps per day (odds ratio (OR) = 0.96, 95% CI = 0.94-0.99, p = 0.01), physical fitness (OR = 0.99, 95% CI = 0.98-0.99, p < 0.01), and PRO-PF (OR = 0.97, 95% CI = 0.94-1.00, p = 0.03) were associated with early trial discontinuation. Optimal cutoff values were < 900 steps for physical activity and < 285 m for physical fitness. PPV for early trial discontinuation was 100% in patients who walked both < 1500 steps per day and < 300 m in 6 min.

Conclusions: Objective smartphone measurements of physical activity and fitness are associated with early trial discontinuation. However, cutoff values should be externally validated in a larger cohort before implementation in clinical practice.

Keywords: Early trial discontinuation; Physical activity; Physical fitness; Smartphone measurements.

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Conflict of interest statement

The authors declare that they have no conflict of interest. We have full control of all primary data and we agree to allow the journal to review the data if requested.

Figures

Fig. 1
Fig. 1
Valid measurements of physical activity, physical fitness, and physical function. 6MWT = six-minute walk test, EORTC = European Organisation for Research and Treatment for Cancer, QLQ-C30 = Quality of Life Questionnaire-C30, GPS = global positioning system
Fig. 2
Fig. 2
Graphic representation of the association between physical activity (a), physical fitness (b) and PRO-PF (c) and early trial discontinuation. 6MWT = six-minute walk test, PRO-PF = patient-reported outcome of physical function, OR = odds ratio, 95% CI = 95% confidence interval

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